Cleared Traditional

OXY-OFF(TM)

K863510 · B&B Medical Technologies, Inc. · Anesthesiology
Oct 1986
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K863510 is an FDA 510(k) clearance for the OXY-OFF(TM), a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY), submitted by B&B Medical Technologies, Inc. (Orangevale, US). The FDA issued a Cleared decision on October 22, 1986, 43 days after receiving the submission on September 9, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2350.

Submission Details

510(k) Number K863510 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1986
Decision Date October 22, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BXY — Flowmeter, Calibration, Gas
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2350